01
Qualification
DQ, IQ, OQ and PQ for cleanrooms, HVAC systems, compressed air, pharmaceutical water and process equipment. We derive the test scope from the risk assessment.
Industry
Medical devices
In the medical device industry, too, production environments and process equipment must be demonstrably fit for purpose. The regulatory framework differs from pharma, for example ISO 13485 and, for the US market, 21 CFR Part 820, which since February 2026 has referenced ISO 13485 as the QMSR. The logic of requirement, risk assessment and evidence is the same.
Focus
Typical topics in medical devices.
01
Cleanrooms in production
Qualification of cleanroom areas for assembly, packaging and critical process steps to ISO 14644.
02
Process equipment
Qualification of equipment and facilities as the basis for process validation.
03
Risk-based documentation
Risk assessments and traceability that connect to your quality management system.
04
Audits
Technical preparation for audits by notified bodies, authorities or customers.
Services
Relevant services.
02
GMP documentation
Qualification master plan, risk assessment, URS, room book, test plans and SOPs. Every requirement can be traced to its evidence.
03
GMP consulting
Joining running projects, Annex 1 gap analyses and audit preparation. At the end you know where you stand and what to do next.
Other industries
Contact
Tell us briefly about your project.
You will get a personal reply with a first assessment: what scope makes sense, how we would approach it and which documents you will need.